NCX · System, Hypothermia, Intravenous, Cooling

Device class

Class II

Regulation 870.5900

Total clearances

2021-12-20 → 2023-01-13

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.5900

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Zoll Circulation, Inc.	3	0	2023-01-13

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
33974	CPT	—	Medium	Extracorporeal membrane oxygenation/cooling; insertion of peripheral (arterial and venous) cannulae
33975	CPT	—	Medium	ECMO/cooling; centrifugal, roller head, or other pump component

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2023-01-13	K223746	Zoll Circulation, Inc.	Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
2022-06-02	K220008	Zoll Circulation, Inc.	Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
2021-12-20	K213031	Zoll Circulation, Inc.	Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console